CN1407906A - Miniaturized needleless injector - Google Patents

Miniaturized needleless injector Download PDF

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Publication number
CN1407906A
CN1407906A CN01805946A CN01805946A CN1407906A CN 1407906 A CN1407906 A CN 1407906A CN 01805946 A CN01805946 A CN 01805946A CN 01805946 A CN01805946 A CN 01805946A CN 1407906 A CN1407906 A CN 1407906A
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CN
China
Prior art keywords
needleless injector
hollow plunger
nozzle
liquid container
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN01805946A
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Chinese (zh)
Other versions
CN1179763C (en
Inventor
乔基姆·艾彻
约翰尼斯·格瑟
伯恩德·齐伦伯格
拉尔夫·C·赖姆霍尔兹
克努特·埃尔伯斯
斯蒂芬·亨克
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Boehringer Ingelheim International GmbH
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Boehringer Ingelheim International GmbH
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Publication of CN1407906A publication Critical patent/CN1407906A/en
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Publication of CN1179763C publication Critical patent/CN1179763C/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3128Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/204Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically connected to external reservoirs for multiple refilling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3145Filters incorporated in syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525Dosing
    • A61M5/31531Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31555Mechanically operated dose setting member by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31563Mechanically operated dose setting member interacting with a displaceable stop member

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Needleless injectors for liquids are known from the art in a variety of designs that are adapted to different conditions of application. The inventive needleless injector is designed as a hand-held device. It comprises a lockable tensioning system, an energy-storing spring (36), a hollow piston (37) displaceable within a cylinder (38), and a nozzle (39). The hollow piston is provided with a valve body on its one end. The storage container (44) for the liquid is disposed within the housing. The lockable tensioning system is tensioned by counterrotating the two housing parts (31; 32), thereby withdrawing the hollow piston (37) from the cylinder (38). At the same time the amount of liquid required for the injection is withdrawn from the storage container (44) and transported through the hollow piston to the pump chamber (43). When the lockable tensioning system is released, the amount of liquid is ejected from the pump chamber through the nozzle. The needleless injector is easy and reliable to handle also for unpracticed people. It is used for intracutaneous injections of a medical liquid into biological tissue, for injecting a liquid containing an active substance into a plant or for injecting a liquid through a membrane into the space behind said membrane.

Description

Miniaturized needleless injector
The present invention relates to a kind of hand-held, especially miniaturized needleless injector, utilize it can be with a kind of liquid intradermal injection to as in human body or the animal tissue.The present invention is intended to enlarge the range of application of this syringe.
Liquid among the present invention is preferably solution, suspension or the disperse liquid that contains a kind of active substance, and this active substance can be the pharmacological active substance that is used for the treatment of human body or animal body or can be and is used to the material diagnosing or improve looks.
Non-medicinal active substance for example can be used for fields such as plant protection insecticide, antibacterial, root-inducing hormone, inhibition growth stimulator or fertilizer.Needleless injector of the present invention can realize environmentally friendly application to the material that these systems work, because active substance is applied directly in the plant.
EP 0063341 and EP 0063342 disclose a kind of needleless injector, and it comprises a piston pump that is used to extrude institute's injecting fluid, and this piston pump is driven by a motor by a kind of piezodielectric that is subjected to.Liquid container is that side direction is installed on the piston pump.When the piston pumpback with the needed amount of liquid of a shot through an access road and a check valve suction pump intracavity.In case piston is then pressed to nozzle with liquid through exit passageway towards the motion of nozzle body direction, and it is extruded.The piston of piston pump is a kind of filled circles piston.
EP 0133471 has described a kind of Needleless injection device, and it is by from a siphon casket, drive through the carbon dioxide pressurized of a particular valve.
EP 0347190 discloses a kind of vacuum compression gas syringe, wherein by the degree of depth that enters of gas pressure scalable institute injectable drug, and can be regulated the volume of medicine by the stroke of piston.
EP 0427457 discloses a kind of needleless hypodermic, and it is operated through a secondary valve by Compressed Gas.Injection is arranged in an ampoule (Ampulle), and this ampoule places in the protection valve jacket that is fixed in the injector housing.Ampoule is placed in the end of piston rod, and nozzle is positioned at the other end of ampoule, and its diameter reduces gradually towards the ampoule end.
WO 89/08469 provides a kind of disposable needleless injector, and WO 92/08508 discloses a kind of needleless injector for three injection uses.The ampoule that medicine is housed is screwed in an end of driver element, and wherein piston rod places the opening of ampoule.Ampoule is equipped with the nozzle that medicine can be discharged at the one end.A movably sealed plunger is arranged the middle part longitudinally about ampoule greatly.Should want injected dose to regulate by the degree of depth that is screwed into of ampoule.The piston rod that stretches out behind the drive unit drives syringe goes back with hand push.These two kinds of syringes are all operated with Compressed Gas.
WO 93/03779 discloses a kind of needleless injector with two housing sections and side direction liquid container placed on it.The driving spring of piston by a CD-ROM drive motor to its stress application.In case nozzle is pressed on injection position and makes two part displacements toward each other of housing, then retracting spring.Be provided with a valve respectively at the suction passage of liquid and the outlet of measuring room (Dosierkammer).
WO 95/03844 discloses another kind of needleless injector.This syringe comprises a liquid fill tube, at the one end nozzle that liquid can be discharged is arranged.It is sealed by a medicated cap shape piston that can in tube, move at the other end that fills tube.After spring discharges, medicated cap shape piston is passed one section preset distance suitable with amount of liquid to be injected by a preloading spring loaded piston in tube for one.In case nozzle enough firmly is pressed on injection position, then spring triggers.This syringe can be scheduled to for once using or reusing.This tube is arranged on spring-loaded piston the place ahead, and is a kind of fixation kit of syringe.Predetermined piston position as nonexpondable syringe will move a segment distance towards the nozzle direction after each the use.Piston and driving spring can not be adjusted back.The prestressing force of spring is enough big when beginning, can once the whole amount of liquid in the tube be discharged.Only disassembling syringe and the driver part of syringe and a new tube that is full of are fully being assembled, can be once again to the spring stress application.
In some known configurations of needleless injector, the storage liquid container side direction of liquid to be injected is placed by the driver element.When the solid piston pumpback of piston pump, amount of liquid to be injected is sucked in the pump chamber.Access road comprises an inlet valve, and exit passageway comprises an outlet valve.Two valves are all operated with an auxiliary force.
In other structures of needleless injector, the storage liquid container of liquid to be injected is directly as pump chamber, and the impact of the power that is produced when bearing the exhaustjet amount of liquid.
In needleless injector, after the per injection some Compressed Gas is sewed away with the Compressed Gas operation.Pressurization-gas cascade can be changed in case of necessity, but Compressed Gas can't be directly filled again.In this syringe, in case driver element is then changed in the pressurization-gas cascade emptying.
Therefore, the technical problem to be solved in the present invention provides a kind of simple in structure and can repeatedly use, be particularly suited for repeating to discharge the needleless injector of predetermined liquid amount.Repeatedly the total amount of liquid that uses the back to be discharged should be preferably greater than the amount of liquid that is held in the storage liquid container.Should take out a plurality of liquid components continuously or once just store amount of liquid taking-up contained in the liquid container from the storage liquid container one, and with its discharge.This storage liquid container should be able to be changed easily.Must produce an enough big mechanical thrust (momentum) to predetermined amount of liquid, thereby make the predetermined liquid amount penetrate a diaphragm, thin film or biological tissue.
According to the present invention, above-mentioned technical problem solves with needleless injector by a kind of like this liquid: this needleless injector is a hand syringes with a cylindrical shell, and comprises a storage liquid container.Housing mainly is made up of two parts.This two housings part is connected in removable mode or in non-disconnectable mode each other, and is arranged to and can rotates relatively.Needleless injector comprises the locking stress mechanism that a spring-operated drives, and it was applied in stress before extruding the predetermined liquid amount, and had a flip flop equipment.On the expelling means of locking stress mechanism, fixed a hollow plunger that driven by locking stress mechanism.This hollow plunger movably is arranged in the cylinder body.It stretches out outside the cylinder body with the one end.Preferably at its other end one valve body is installed, this valve body is a unique valve body of this needleless injector.The nozzle with at least one jet hole is installed in end at cylinder body.Space between this nozzle and this hollow plunger end is a pump chamber.One storage liquid container is arranged in housing.This storage liquid container is a kind of container that separates with needleless injector, and preferably is connected with the removable mode hollow plunger end outer with stretching out cylinder body by interference fit., determine by the stroke and the cross section of hollow plunger during at expelling means and coupled hollow plunger through the predetermined liquid amount that hollow plunger is delivered in the pump chamber toward swivel motion.
This locking stress mechanism comprises: one as driving flange expelling means, that be spring loaded, one applies prestressed actuator to spring, one locking component is made the link stopper that moves back and forth betwixt for driving flange for two, and a device that is used to trigger locking component.The stroke that drives flange is accurately limited by two link stoppers.A force transfer mechanism is set between energy-stored spring and the actuator to the spring stress application.This locking component is a ring-type, and has the locking surface that is meshed.As energy accumulating device, can adopt a preferred cylindrical helical spring or a disc spring or a leaf spring, they play the effect of extension spring or stage clip.
Can be by a direct actuator to the energy-stored spring stress application.To this, move the driving flange by an axial action external force.When big spring power, it is favourable adopting a force transfer mechanism (as the spiral slide moving mechanism), utilizes this mechanism to pass through an impressed torque to the spring stress application.This mechanism is arranged on this spring and to the single thread between the actuator of this spring stress application or many thread transmissions.
This driving flange can have a glass type structure, and the ring set that drives flange for example comprises two zigzag openings, and two sawtooth in the upper case portion can produce slip on this two zigzag opening.
Average spring force can be 10 to 150 newton (N), and spring force approximately changes 10% average spring force between the two positions of locking stress mechanism expelling means.
Locking component can be one its radially elastically deformable ring or be the stiffening ring of a Tape movement convex shoulder or be the stiffening ring of a band shaping leaf spring or be one and bear the prestressed ring of one or more metal spring.This ring can seal, or opening; It can be made of a plurality of parts.This locking component is arranged to and can be moved with the perpendicular plane of housing axis at one, or can be out of shape in this plane.
Other details of relevant a kind of spring driven locking stress mechanism are described in DE 19545226.
A hollow plunger that is driven by locking stress mechanism is fixed in the expelling means of this locking stress mechanism.Hollow plunger inserts in the cylinder body, and has a segment length to reach outside the cylinder body; It movably is configured in the cylinder body.
In cylinder ends a nozzle has been installed.This jet hole can have 10 to 500 microns, be preferably 50 to 150 microns hydraulic diameter.Jet hole can have 50 to 500 microns, be preferably 100 to 300 microns length.
When nozzle had a plurality of jet hole, the longitudinal axis of jet hole extended parallel to each other, and perhaps tilted each other in divergent shape.When nozzle had a plurality of jet hole, it can have different liquid diameters.
Nozzle can be a rectangular parallelepiped that is assembled into by two silicon plates, and for example wide is 1.1 millimeters, and length is 1.5 millimeters, and height is 2.0 millimeters.This rectangular parallelepiped has the plane triangle opening of a treaty 400 micron thickness on two plate contact surfaces, and ends at the single jet hole of one 50 microns wide, 50 micron thickness and 200 microns long.Suitable is the elastic forming spare that is surrounded by a kind of accurate cooperation on the whole limit of this nozzle.The in-profile of this elastic forming spare and the exterior contour of nozzle match, and the exterior contour of elastic forming spare then matches with the in-profile of the nozzle bearing that preferably is made of metal.The percussion load that this kind " floating type installation " occurs when making the nozzle made by fragile material for normal use needleless injector is also insensitive.
Preferably be arranged in valve body that is preferably single-piece of end installation of cylinder body at hollow plunger, this valve body is guided by hollow plunger, and disposes can move axially mode with respect to cylinder body.Valve body mainly moves with hollow plunger.Valve body preferably has one around the rotational symmetric shape of single shaft, as a cylindrical or truncated cone shape.Its diameter can be less than the diameter that can make the cavity of movable configuration for valve body.Valve body can rotate around its axis.The axis of valve body all the time with the axis keeping parallelism of hollow plunger.A definite sealing surface is provided on the entrance side of valve body.The distance that valve body moves with respect to cylinder body is subjected to the restriction of a link stopper.When valve body is resisted against this position of definite sealing surface, valve cuts out.
At nozzle and the space that is installed between the valve body in the hollow plunger is pump chamber, can be provided with a filter in the nozzle end (promptly in the passing away at liquid) of pump chamber, is preferably depth filter element.If liquid to be injected contains particle, then the hole dimension of filter should match with particle size.
The further details relevant with hollow plunger and valve body provides in DE 19536902.
This locking stress mechanism and energy-stored spring preferably by these two housing parts are rotated relative to one another, and preferably through a spiral slide moving mechanism to this locking stress mechanism stress application.This moment of torsion produces with hands or motor.
The preferred actual external diameter that equals hollow plunger of the diameter of cylinder body on its whole length.Cylinder body can be fixedly mounted in one of them housing parts.In addition, but cylinder body be installed in this housing parts in the axial displacement mode.This movable cylinder body remains on its resting position by a back-moving spring.
But two link stopper stationary positioned that the confession expelling means is used are in housing.In addition, the position of one of them link stopper can change vertically.Thereby, can under the constant situation of hollow plunger external diameter, change the volume of pump chamber.When other structures of needleless injector are constant, can change the liquid output by the position that changes a link stopper.
Thereby the stroke of travel position hollow plunger in needleless injector of expelling means is subjected to the restriction of two link stoppers.When given link stopper position, thereby the stroke of the travel position hollow plunger of expelling means is all constant in per injection.
By a flip flop equipment, make locking component be parallel to that plane of a loop moves or produce radial deformation along plane of a loop.In being fixedly installed in the intravital cylinder body of shell, flip flop equipment can be operated by the triggering button of an available finger presses, and discharges locking component.In movably being installed on the intravital cylinder body of shell, cylinder body is defeated down to drive flip flop equipment against back-moving spring, locking component is thrown off.
In enclosure interior a storage liquid container is set, this storage liquid container and needleless injector are separated; Its with hollow plunger on be connected with opposed that end of pump chamber.The liquid that the end of this hollow plunger is store in the liquid container covers.
The storage liquid container that is connected with hollow plunger also is connected with expelling means in addition.But this connection can be a kind of demolition or non-removable socket connection, and wherein expelling means is provided with a plurality of clasps, and these clasps are engaged in the peripheral extension slot of storing on the liquid container when the storage liquid container is inserted in the needleless injector.
Predetermined amount of liquid of discharging depends on the stroke and the cross section thereof of hollow plunger, and the stroke of hollow plunger is defined by two link stoppers that drive flange.
A kind of seal bootr that pipettes need be set in nozzle the place ahead, thereby reach protection jet hole when depositing needleless injector before the use during use and prevent that liquid from being polluted and evaporating.
Two parts of housing, locking stress mechanism, cylinder body and storage liquid container are preferably by plastics, make as polybutylene terephthalate.Hollow plunger is preferably by metal, make as the high-quality steel.
Valve body can be made by metal, pottery, glass, gem, plastics or elastomer.
Nozzle can be made by metal, plastics, glass, silicon or gem (as sapphire, ruby or corundum).
Filter is preferably made by sintering metal or sintered plastics.
Needleless injector is preferably made hand held injector.It can be hold by one hand and operate when injection.Cylinder body, hollow plunger, valve body, nozzle and the filter that may comprise are micro parts.
The working method of needleless injector is described below.
When needleless injector is not used or used but between the storage period between the double injection, needleless injector remains static.Energy-stored spring is in the primary stress situation.Expelling means abuts in the restriction expelling means on the link stopper that resting state moves.The hollow plunger degree of depth is immersed in the cylinder body.Between hollow plunger end and nozzle inboard, only there is a little at interval.Locking component is in disengaging configuration.
When two housing parts rotated relative to one another, locking stress mechanism was subjected to stress.Expelling means leaves cylinder body along moving axially, and the stress of energy-stored spring is increased.At the same time, hollow plunger is pulled out the outer segment distance of cylinder body and the pump chamber size is increased.A part of length of hollow plunger still stretches into cylinder interior.At the same time, a part of liquid of storage in the liquid container is by hollow plunger and cross valve body and deliver in the pump chamber, makes pump chamber be filled with liquid.Amount of liquid in the pump chamber is actual to equal the amount of liquid that a shot is discharged.Expelling means moves till locking component is jumped into the position of engagement.This triggering button is slightly given prominence to outside the housing in having the needleless injector that triggers button.
The nozzle end of needleless injector is placed injection position, and exert pressure.In having the needleless injector that triggers button, should trigger button with a finger manipulation, be pressed in the housing.Utilize this mode to shift locking component onto disengaging configuration, trigger injection.In the needleless injector that has the packaged type cylinder body, make syringe be pressed in injection position with hands, and increase power is to overcome back-moving spring power with its nozzle side one end.Push cylinder body in the housing this moment, and locking component is pushed disengaging configuration and triggers injection.Lift when leaving injection position in needleless injector, back-moving spring pushes back resting position with cylinder body.
In case locking component enters disengaging configuration, then execute stress energy-stored spring power K during the interval Δ t through expelling means, hollow plunger, and the valve of closing of hollow plunger end and acting on the liquid in the pump chamber, liquid quality m obtains speed Δ v like this, thereby obtain mechanical momentum (mechanisch Impuls) K * Δ t=m * Δ v, just penetrate at a high speed, and penetrate tissue at Intradermal from nozzle.Injection back needleless injector is in resting position again.
Needleless injector of the present invention can be used for the active substance (as medicine) of flowing product is expelled to human body or animal tissue in the intradermal injection mode in human medical and animal medicine.The example of suitable pharmaceutical products is mainly: analgesic, vaccine, anti-diabetic with agent, hormone, contraceptive, vitamin, antibiotic, tranquilizer, antimicrobial with agent, aminoacid and crown tremulous pulse agent.
Pharmaceutical preparation can be solution, suspension or Emulsion.In suspension, average particle size particle size should be above 15 microns, preferred 10 microns.
Making the active substance dissolving, suspend or emulsive suitable agent and the additive in case of necessity used, can be as water, alcohol, alcohol-aqueous mixtures and the aqueous emulsion of oil or the oil emulsion of water.What belong to these has: sterile purified water, ethanol, propylene glycol, benzyl alcohol, ethanol-water mixture, oil (as Oleum Cocois, Oleum Arachidis hypogaeae semen, soybean oil, Oleum Ricini, sunflower oil), fatty acid ester (as isopropyl myristic acid ester, isopropyl cetylate and ethyl oleate), triglyceride, triacetin, Suo Keta (sloketal) and propylene glycol.May comprise additive in the prescription, such as preservative agent and be used to adjust the acid or the alkali of pH value.
Can utilize needleless injector to be injected into the predetermined liquid amount in the blade of plant or the stem or inject the space at thin film rear via a thin film.
Needleless injector of the present invention has following advantage:
Have shape easy to use, the storage liquid container is arranged in injector housing;
Can for repeatedly, reach hundreds of time injections most and use (taking out injecting fluid) from one or more storage liquid container;
Except the valve that is positioned at the hollow plunger end, no longer need any other valve;
Even have high spring force, still can by unskilled person easily operational lock answer force mechanisms, and can come stress application by the less power of spiral slide moving mechanism cost;
Just can trigger locking stress mechanism when compressing injection position with proficiency finger pressure triggering button or with needleless injector;
Need not to change driver element, and only change the storage liquid container;
The valve that is installed in the hollow plunger end does not need auxiliary force to operate, and closes very soon;
The variation of pump chamber can realize by the position that changes one of two link stoppers;
The mechanical momentum of amount of liquid to be injected can be adjusted to the required thickness that penetrates the degree of depth of tissue or the thin film that penetrates suitable.
The storage liquid container is suitable for the situation of containers store (reaching the several years in case of necessity), and is suitable for being connected with syringe; Its design structure is irrelevant with the demand of the pump chamber that is positioned at nozzle the place ahead;
Thrust when the storage liquid container does not bear injection;
It is convenient that the storage liquid container is changed;
The predetermined needed applicating liquid amount of behaviour in service easily the diverse location in injection areas with componentwise repeatedly continuously injection realize.
Needleless injection is far smaller than the injection of employing injection tube for the influence of injection position.
Below in conjunction with accompanying drawing the present invention is described in detail.Fig. 1 is for triggering the longitudinal section of the needleless injector of button by the band under a kind of the remaining static, wherein the cylinder body fixed configurations is in a housing parts.Fig. 2 be in energy-stored spring be applied under the stress state not with the longitudinal section of the needleless injector that triggers button, wherein cylinder body is disposed in the housing parts in movable mode.
Fig. 1 illustrates two and connects and be arranged to relatively turnable housing parts 1 and 2 each other in removable mode.Situation about remaining static corresponding to locking stress mechanism shown in this figure, expelling means shown in the figure 3, be in the disengagement situation locking component 4, act on the locking component triggering button 5 and the compression form of springs energy storage helical spring 6.The hollow plunger 7 that is inserted in the cylinder body 8 is fixed in the expelling means 3.The nozzle 9 that has jet hole 10 is installed in cylinder ends.Filter 11 is positioned at the nozzle front portion.The nozzle end of hollow plunger is provided with valve body 12.Pump chamber 13 is between valve body and filter.Storage liquid container 14 is arranged in the so-called free space of helical spring inside; It is inserted on the hollow plunger with flange 15, and by interference fit 19 it is remained on the hollow plunger.Surround and helical springly shroud 16 and be connected in the shape mode (formschluessig) that matches with housing parts 1.3 of expelling means abut on the link stopper 17.This nozzle is protected with a removable seal bootr 18.
Fig. 2 illustrates two and connects and be arranged to relatively turnable housing parts 31 and 32 each other in removable mode.Be in the situation of stress application state shown in this figure corresponding to locking stress mechanism, expelling means shown in the figure 33, be in the locking component 34 of engagement situation and be in the energy storage helical spring 36 of impaction state.The hollow plunger 37 that is inserted in the cylinder body 38 is fixed in the expelling means 33.The nozzle 39 that has jet hole 40 is installed in cylinder ends.The nozzle end of hollow plunger is provided with valve body 42.Pump chamber 43 is between valve body and nozzle.Storage liquid container 44 is arranged in the so-called free space of helical spring inside; It is inserted in the hollow plunger with flange 45, and by interference fit 49 it is remained on the hollow plunger.Surround and helical springly shroud 46 and be connected in the shape mode of matching with housing parts 31.33 of expelling means abut on the link stopper 47 of the locking component 34 that is meshed.Cylinder body 38 is arranged in the housing parts 31 with the axially-displaceable flowing mode; And make it remain on resting position by a spiral type back-moving spring 48 that plays the compression spring action.Cylinder body 38 has a not shown flip flop equipment, in case press against injection position and cylinder body 38 antagonism back-moving springs are tried hard to recommend in the housing parts 31 in needleless injector, flip flop equipment is thrown off locking component 34.Represent the displacement of actuator between two link stoppers with a, the stroke of hollow plunger equals this displacement.
Fig. 2 illustrates can be for the needleless injector of injection, the skin that is tensioned 35 that nozzle 39 roof pressures are schematically illustrating; When further roof pressure injection position, needleless injector will be triggered, and liquid is expelled in the skin 35 from pump chamber 43.
Fig. 3 and 4 illustrates the end and the expelling means of storage liquid container in another embodiment.Hollow plunger is inserted in the storage liquid container among Fig. 3, but both do not connect as yet.
Fig. 3 is the partial, longitudinal cross-sectional of (three shell-types) storage liquid container 54, and the shell of storage liquid container is a rigid sleeve 55 that has a peripheral extension slot 52.The storage liquid container is by stopping up 56 sealings, and this obstruction 56 is transited into the insertion connection tube 58 that has interference fit 59.With the vertical section expelling means 53 and the hollow plunger 57 that is fixed therein are shown.Expelling means has a plurality of clasps 51 in the side towards the storage liquid container.
Among Fig. 4, the storage liquid container is connected with expelling means with hollow plunger, be connected with hollow plunger by interference fit 59, by with store liquid container in the clasp 51 that is meshed of peripheral extension slot 52 be connected with expelling means.
Shown in Fig. 3 and 4, being connected between storage liquid container and the expelling means is that the peripheral extension slot 52 by clasp 51 with circular shoulder and semi-circular cross-section realizes that this connection is a kind of dismountable socket connection.
For a kind of socket connection that can not throw off is provided, can select to have the clasp of zigzag shoulder and the peripheral extension slot of a triangular-section.Embodiment 1: a kind of structure of needleless injector of the present invention
A kind of needleless injector of making intradermal injection in biological tissue has following feature:
Housing has about 20 mm outer diameter and about 70 mm lengths, and it is to be made by polybutylene terephthalate that two housing sections, locking stress mechanism and spring shroud.Cylinder body is made by polybutylene terephthalate equally; It has 5 mm outer diameter and 1.60 millimeters internal diameters.Nozzle is made by quartz, and jet hole has 140 micron diameters and 220 microns length.High-quality steel hollow plunger has 1.59 mm outer diameter and 0.35 millimeter internal diameter.Ram travel is 12 millimeters.Valve body is made by elastomer; It is the disc of 2 millimeters thick and 1.60 mm outer diameter, and this disk is provided with axially open on its periphery surface, and liquid enters pump chamber by these openings valve body of flowing through.The hollow plunger end is provided with a groove for the valve body embedding.The amount of liquid of being discharged is about 23 cubic millimeters, and removable storage liquid container has about 11 cubic centimetres volume.Embodiment 2: a kind of intradermal application of liquid
Using needleless injector of the present invention contains every liter of distilled water in the Canis familiaris L. of a kind of injection solution by injection of skin to two a process anesthesia of 20 gram glucosan fluoresceins (UW 3000)., 4.5 milliliters glucosan luciferin solution are charged in the storage liquid container of needleless injector for this reason, and will store on the hollow plunger that liquid container is connected to syringe.The locking stress mechanism of syringe is carried out repeatedly tensioning and unclamps, thereby the air in hollow plunger, pump chamber and the nozzle is discharged.Subsequently needleless injector is placed the Canis familiaris L. abdomen area shaved in advance the hair skin part and trigger.This program repeats for several times.
Take blood sample with regular intervals from Canis familiaris L., determine the glucosan fluorescein content in the blood plasma.Its result proves the performance of needleless injector of the present invention.Embodiment 3: the vitro examination of viral float
In laboratory, the use of needleless injector is studied to confirm when suspension was extruded by the nozzle of needleless injector, whether the live virus of suspension had reduced survival ability.
Determine, discharge in the collected viral float in back, bigger DNA viruses (Test Virus: vaccinia virus) only reduce about 1log in needleless injector 10PFU (plaque shaping unit), less RNA viruses (Test Virus: bovine viral diarrhea virus) then reduce still less (about 0.5log 10PFU).Embodiment 4: use a kind of vaccine with improvement live virus in vivo
But the research and utilization needleless injector is inoculated the application power of improvement live-virus vaccine float in animal experiment.In this research, all obtained affirmation in the safety that utilizes needleless injector to inoculate and the compatibility and this effectiveness of application.
Six Canis familiaris L.s with age health are divided into two groups, and the 1st group comprises two Canis familiaris L.s, and the 2nd group comprises four Canis familiaris L.s, and each also respectively injects the improvement live vaccine of three hepatitis infectiosa canis viruses (canine adeno virus) two treated animals with the injection of three weekly intervals.
In the 1st group, according to makers' suggestion utilize a subcutaneous injection tube with 1 milliliter hepatitis infectiosa canis virus vaccine (CAV-1) (Galaxy DA2ppvL+Cv, SNo 610041; Solvay Animal Health Inc. (Suo Wei animal health company)) carries out intramuscular injection.In the 2nd group, by the vaccination of experimentizing property of needleless injector hepatitis infectiosa canis virus.
The experimental vaccine (CAV-2) that is used to inject the 2nd treated animal is made by a kind of attenuated strain of hepatitis infectiosa canis virus, and titer is 7.2log 10TCID 50/ 60 microlitres (TCID=TCID).Constantly divide in each inoculation and to carry out (six times 10 microlitres=per injection amount is 60 microlitres) for six times.The injection areas of Canis familiaris L. back has been shaved hair, marks six injection positions respectively with ballpoint pen.
Confirm the effect of inoculating by determine the quantity of the virucidin in the dog serum respectively in per injection three all backs.
By observing injection position in inoculation after six hours, observing every day and finish to confirm the compatibility then up to animal experiment.Injection areas is taken pictures, and the check result behind the record touch injection position.
This test is pointed out:
In the 2nd treated animal, can see that injection position was rubescent slightly in preceding 2 to 3 days, only can feel and continue 1 to 2 day temporary transient swelling by touch, this kind is slight and local response that can allow the people accept fully is relevant with the local expansion of the improvement live virus of being injected probably, therefore be considered as vaccine produce good performance the phenomenon that must have.This explanation obtains the support of the following fact: after utilizing needleless injector injection normal saline solution solution, can not see variable color, also can't see swelling or only see slight temporary transient swelling.
Utilize virus neutralization tests to confirm effect, the results are shown in Table 1, maximum titer still can be be neutralized of hepatitis infectiosa canis virus.
After three weeks of inoculation for the first time, in the serum of two groups of all animals, can detect virucidin.Can find slight stiffening effect after second and third time inoculation.
The inoculation of the experimental hepatitis infectiosa canis virus vaccine that carries out with needleless injector and the commerce of subcutaneous injection tube are effective equally with the intramuscular inoculation of vaccine.
Table 1: hepatitis infectiosa canis virus; The viral acid-base titration degree of dog serum
The VN-titer of Canis familiaris L. dog serum
Test No. Label symbol For the first time inoculate back 21 days For the second time inoculate back 21 days Inoculate back 21 days for the third time
Utilize the subcutaneous injection tube to make the CAV-1 commerce vaccine of intramuscular injection
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Utilize needleless injector to make hypodermic CAV-2 experimental vaccine
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Claims (25)

1. hand-held needleless injection of liquids device, it comprises a housing and a storage liquid container, wherein:
-this housing comprises that two are connected to each other and can counterrotating housing parts (1,2; 31,32);
-this needleless injector comprises that has the expelling means (3 that can move and have a flip flop equipment between two link stoppers (17,47); 33; 53) locking stress mechanism reaches one and is fixed on this expelling means (3; 33; 53) hollow plunger (7 that is driven in and by this locking stress mechanism; 37; 57), wherein this hollow plunger movably is arranged on a cylinder body (8; 38) in, and have a unique valve body (12; 42), be furnished with one and have a jet hole (10 at least in this cylinder ends; 40) nozzle (9; 39), and the space between this nozzle and this valve body forms a pump chamber (13; 43);
-this stores liquid container (14; 44; 54) be arranged in this housing, be the container that separates with this needleless injector, and by means of interference fit (19; 49; 59) outer with stretching out this cylinder body hollow plunger end is connected;
-this hollow plunger (7) is entered amount of liquid that this pump chamber (43) carried by this hollow plunger from this cylinder body (8) when outwards spurring determine by the stroke (a) and the cross section of this hollow plunger; And
The stroke (a) of-this hollow plunger in this needleless injector determined by the position of two link stoppers (17,47).
2. according to the described needleless injector of claim 1, wherein:
Two housing parts (1,2 of described housing; 31,32) be connected in removable mode each other.
3. according to claim 1 or 2 described needleless injectors, wherein:
-described nozzle (9; 39) only comprise that a jet diameter is 10 to 500 microns, is preferably 50 to 150 microns jet hole (10; 40); And
-this jet hole (10; 40) length is 50 to 500 microns, is preferably 100 to 300 microns.
4. according to any one described needleless injector in the claim 1 to 3, wherein:
Described nozzle (9; 39) comprise a plurality of jet holes that may have the different jet diameter.
5. according to any one described needleless injector in the claim 1 to 4, wherein:
Described nozzle (9; 39) jet hole that comprises that a plurality of longitudinal axis extend parallel to each other or tilt each other in divergent shape.
6. according to any one described needleless injector in the claim 1 to 5, wherein:
The position of one link stopper thereby the stroke of this hollow plunger (a) are changeable.
7. according to any one described needleless injector in the claim 1 to 6, wherein:
Can pass through these two housing parts (1,2 with hands; 31,32) rotate relative to one another to this locking stress mechanism stress application.
8. according to any one described needleless injector in the claim 1 to 7, wherein:
Can pass through these two housing parts (1,2; 31,32) rotate relative to one another through a spiral slide moving mechanism to this locking stress mechanism stress application.
9. according to any one described needleless injector in the claim 1 to 8, wherein:
Described locking stress mechanism comprises a helical spring as energy accumulating device (6,36), disc spring or leaf spring.
10. according to any one described needleless injector in the claim 1 to 9, wherein:
Described nozzle (9; 39) by metal, plastics, glass, silicon or gem are made as sapphire, ruby, corundum.
11. according to any one described needleless injector in the claim 1 to 10, wherein:
The described storage liquid container (14 that separates; 44; 54) be a kind of removable storage liquid container, and described expelling means (53) is suitable for the storage liquid container of admitting this to separate.
12. according to any one described needleless injector in the claim 1 to 11, wherein:
The described storage liquid container (14 that separates; 44; 54) with described hollow plunger (7; 37; 57) be connected in removable mode, and can move at the intravital stroke of this shell along with this hollow plunger.
13. according to any one described needleless injector in the claim 1 to 12, wherein:
-described storage the liquid container (54) that separates is connected in removable mode with described expelling means (53) with described hollow plunger (57); And
-this expelling means (53) is provided with clasp (51), and this clasp (51) is engaged in the peripheral extension slot (52) of this storage liquid container.
14. according to any one described needleless injector in the claim 1 to 13, wherein:
The nozzle-end of described needleless injector is provided with a seal bootr (18).
15. according to any one described needleless injector in the claim 1 to 14, wherein:
Towards a side of pump chamber a filter (11) is arranged at described nozzle.
16. according to any one described needleless injector in the claim 1 to 15, wherein:
The described storage liquid container (14 that separates; 44; 54) be filled with a kind of liquid preparation that is selected from following medicament: analgesic, vaccine, anti-diabetic with agent, hormone, contraceptive, vitamin, antibiotic, tranquilizer, antimicrobial with agent, aminoacid and crown tremulous pulse agent.
17. according to any one described hand-held needleless injection of liquids device in the claim 1 to 16, it comprises a housing and a storage liquid container, wherein:
-described housing comprises that two are connected to each other and can counterrotating housing parts (1,2; 31,32);
-described needleless injector comprises that has the expelling means (3 that can move between two link stoppers (17,47); 33; 53) and a helical spring (6; 36) locking stress mechanism can pass through these two housing parts (1,2; 31,32) rotate relative to one another through a spiral slide moving mechanism to this locking stress mechanism stress application, and this locking stress mechanism is provided with a flip flop equipment: and
-this needleless injector comprises that is fixed on this expelling means (3; 33; 53) hollow plunger (7 that is driven in and by this locking stress mechanism; 37; 57), wherein this hollow plunger movably is arranged on a cylinder body (8; 38) in, and have a unique valve body (12; 42);
-be furnished with one in this cylinder ends to have single jet hole (10; 40) nozzle (9; 39), and the space between this nozzle and this valve body forms a pump chamber (13; 43);
-described storage liquid container (14; 44; 54) be arranged in this housing, be the container that separates with this needleless injector, it is connected by means of interference fit (59) the hollow plunger end outer with stretching out this cylinder body, and is connected with this expelling means (53) by means of the clasp (51) in the peripheral extension slot (52) that is engaged on this storage liquid container;
The stroke (a) of-this hollow plunger in this needleless injector determined by the position of two link stoppers (17,47), and
-this storage liquid container (14 separately; 44; 54) be filled with a kind of liquid medicine.
18. any one described needleless injector is applied to a kind of liquid infusion of bioactive substance that contains in a biological tissue in the claim 1 to 17.
19. any one described needleless injector is applied to a kind of liquid infusion of bioactive substance that contains in plant tissue in the claim 1 to 17.
20. any one described needleless injector is applied to a kind of liquid infusion of bioactive substance that contains in an animal tissue in the claim 1 to 17.
21. any one described needleless injector is applied to the vaccine intradermal injection in an animal in the claim 1 to 17.
22. any one described needleless injector is applied to vaccine is subcutaneously injected in the animal in the claim 1 to 17.
23. any one described needleless injector is applied to the vaccine intradermal injection in a human body in the claim 1 to 17.
24. any one described needleless injector is applied to vaccine is subcutaneously injected in the human body in the claim 1 to 17.。
25. any one described needleless injector is applied to a kind of liquid is expelled in the space at this thin film rear by a thin film in the claim 1 to 17.
CNB018059465A 2000-03-03 2001-03-02 Miniaturized needleless injector Expired - Fee Related CN1179763C (en)

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DE10010123A DE10010123A1 (en) 2000-03-03 2000-03-03 Needle-less injector for liquids comprises a tensioning system, an energy storing spring, a hollow piston in a cylinder, and a nozzle

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CN109432553B (en) * 2018-11-19 2024-04-16 北京快舒尔医疗技术有限公司 Syringe head assembly of medicine storage tube of needleless injector, medicine storage tube and needleless injector
CN113613695A (en) * 2019-06-19 2021-11-05 李芝银 Nozzle assembly, injector body and needleless injector comprising same
CN113613695B (en) * 2019-06-19 2023-04-18 李芝银 Nozzle assembly, injector body and needleless injector comprising same
CN111558112A (en) * 2020-04-30 2020-08-21 北京快舒尔医疗技术有限公司 Injection head of needleless injector, needleless injector body and needleless injector
WO2021218108A1 (en) * 2020-04-30 2021-11-04 北京快舒尔医疗技术有限公司 Injection nozzle for needle-free injector, needle-free injector body, and needle-free injector
CN111870456A (en) * 2020-08-04 2020-11-03 张家港江苏科技大学产业技术研究院 Labor-saving mechanical device
CN111870456B (en) * 2020-08-04 2021-09-07 张家港江苏科技大学产业技术研究院 Labor-saving mechanical device

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UA70409C2 (en) 2004-10-15
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PT1263490E (en) 2005-09-30
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